Regulatory Intelligence for MedTech Leaders.
Transform regulatory compliance into a strategic advantage.
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QualiVerse expedited our product code, predicate device, and design planning documents in record time for FDA pre-submission — a true accelerator for our team.
Regulatory Compliance, Reimagined for What's Next.
QMB combines the power of AI-driven innovation and regulatory expertise to accelerate MedTech compliance, New Product Development (NPD) and FDA submissions
Book a DemoBasic compliance isn’t enough. QMB takes you further.
In a fast-moving MedTech world, QMB helps you move beyond checklists—turning regulatory compliance into a growth strategy
The traditional regulatory playbook is broken
we're here to rewrite it.
QualiVerse® automates and accelerates New Product Development & FDA submissions using generative AI and expert oversight—transforming regulatory bottlenecks into a strategic advantage. Built for MedTech leaders, it delivers instant documentation, risk flagg ing, and submission-readiness in a unified, intelligent workspace.
Our team brings deep expertise in regulatory strategy, QMS deployment, and new product submissions. We guide life sciences companies from concept to clearance—streamlining complex processes, reducing risk, and ensuring long-term compliance success.
We empower MedTech innovators with tailored support for clinical trial management, V&V, eQMS transitions, and post-market readiness. Whether scaling quality systems or navigating audits, we help you maintain integrity—and momentum.
Powering smarter submissions
The QualiVerse® platform brings together AI and regulatory expertise to automate classification, identify predicates, and simulate FDA-ready submissions — all in one intelligent workspace.
Strategic support meets smart tech
Beyond automation, QMB embeds real regulatory experts into your process — guiding strategy, validating documents, and giving your team the confidence to move fast and stay compliant.
AI-Driven Docs & Benchmarks
Automatically generate thousands of pages of submission-ready documentation, backed by real-world FDA benchmarks to ensure your application stands up to review — the first time.
Global Standards Built In
QualiVerse® aligns with FDA, EU MDR, ISO 13485, and more — helping you scale globally without getting buried in regulatory red tape.
Traditional Pathway
Save 1-2 years on NPD + submission
Manual research, document generation, and back-and-forth revisions drain time.
High risk of FDA rejections
Due to incomplete files, misclassified codes, or missed benchmarks.
Limited visibility across teams
Siloed data, outdated spreadsheets, and disconnected systems.
Delayed market launches
Caused by slow document prep, compliance bottlenecks, and surprise audits.
With QualiVerse®
Save up to 70% time on New Product Development + Submission
Automated documentation, predicate matching, and smart risk flagging.
Accelerated FDA clearance timelines
Faster review cycles thanks to structured, audit-ready submissions.
Always-on audit readiness
Backed by a proprietary 7-point AI risk model and expert oversight.
Global compliance built-in
FDA, ISO 13485, EU MDR, and more—handled in one platform.
Traditional Pathway
Save 1-2 years on NPD + submission
Manual research, document generation, and back-and-forth revisions drain time.
High risk of FDA rejections
Due to incomplete files, misclassified codes, or missed benchmarks.
Limited visibility across teams
Siloed data, outdated spreadsheets, and disconnected systems.
Delayed market launches
Caused by slow document prep, compliance bottlenecks, and surprise audits.
With QualiVerse®
Save up to 70% time on New Product Development + Submission
Automated documentation, predicate matching, and smart risk flagging.
Accelerated FDA clearance timelines
Faster review cycles thanks to structured, audit-ready submissions.
Always-on audit readiness
Backed by a proprietary 7-point AI risk model and expert oversight.
Global compliance built-in
FDA, ISO 13485, EU MDR, and more—handled in one platform.
As a Physician-led Al-enabled SaMD, we relied on QMB for all our regulatory compliance needs. What differentiate them above the rest is QualiVerse. QualiVerse was able to expedite selecting our product code, predicate device, and design planning documents in a record time for pre-submission with the FDA. This also augmented our investment efforts.
